Once you have determined the viability of your device you can then start on developing the key components such as prototype and trial your device.

During this phase we can support on the following areas:

  • Finalising on product prototype
  • Design history file
  • Risk Management
  • Update regulatory strategy
  • Validation
  • Clinical Evaluation report (Meddev 2.7.1 Rev 4)
  • Usability testing/Human Factors
  • Update re-imbursement strategy

Do you have a question?

Contact us now for a free, no-obligation consultation.